### United States

Department of Agriculture Animal and Plant Health Inspection Service June 201 3 **Final Regulatory Flexibility Analysis**

**Affirmation of Interim Final Rule**  **Docket Number: 00 -**  **108 -**  **1 1**  **RIN 0579 -** **AB35 Chronic Wasting Disease**  **Herd Certification Program and Interstate Movement of Farmed**  **or Captive Deer, Elk, and Moose**

Policy & Program Development Policy Analysis & Developmenti



### Summary This final rule affirms prior regulatory actions that established a voluntary Herd Certification Program (HCP) for the control of chronic wasting disease (CWD) in farmed or captive cervids (deer, elk, and moose) in the United States. The program regulations include CWD monitoring and testing requirements, an d set minimal requirements for interstate movement that will not preempt more restrictive State or local laws or regulations. As at present, herd owners’ interstate marketing decisions may need to account for dissimilar State CWD certification regulations
. H erd owners who choose to participate in the Herd Certification Program will have to meet program requirements for animal identification, testing, and herd management. Other than for cervids moving to slaughter or for research, those that move interstate must be from C ertified herds that have been monitored for a period of at least 5 years and that have not been epidemiologically

linked to herds where CWD has been diagnosed, or captured from a wild cervid population that has been documented to be low ri sk for CWD based on a surveillance program . Some herd owners may

be adversel y affected b y the 5
- year monitoring requirement for interstate movement; however, available research indicates that this minimum period of monitoring is necessary

to provide an ad equate level of protection against the spread of CWD. Most researchers agree that CWD manifests itself within 5 years if the disease is present in a herd of farmed or captive cervids. Man y herd owners have been participating in S tate - level CWD HCPs for at least 5 years and will have met this requirement as a result of being enrolled in a S tate program that becomes an Approved State HCP in the national CWD HCP.ii

Producers who participate in the Herd Certification Program will be required to maintain a compl ete inventory

of their herds, with verification by APHIS or State officials. A phy sical inventory of the animals will be required at the time a herd is enrolled in a CWD certification program and thereafter the animals will need to be phy sicall y assembled for inventory within 3 ye ars of the last phy sical inventory
. An annual herd inventory

—including a review of owner records and an observation of the herd’s unrestrained animals in a viewable, enclosed area

— will continue to be required, but the animals wil l not necessarily need to be physically

assembled and restrained. The inventory

cost is estimated to average about $25 to $30 per deer or elk, including the animals’ phy sical inventory once every

three years and use of eartags for identification. (We do not know of an y farmed or captive moose herds.) Values of farmed or captive deer and elk range widely , depending on the ty pe of animal and market conditions. Based on average per animal values of $2,000 for deer and $2,200 for elk, annual inventory costs are estimated to average less than 2 percent of the value of farmed or captive deer and elk. All on
- farm cervid mortalities, and any cervids on herd inventories sent to slaughter and hunt facilities, must be tested to achieve certified status. Thereafter, all on
- farm mortalities of C ertified cervids will be required to be tested for CWD, to maintain Certified status. There also will be optional confirmatory DNA test provisions for animals that test CWD
- positive. CWD testing will entail submission of the carcass or whole head for tissue sampling and testing , or collection of the tissue sample s by State officials, APHI S employees, acc redited veterinarians, or State
- certified or
- d esignated CWD sample collectors . The estimated cost is about $150 per samp le, equivalent to about 8 percent of the average value of a farmed or captive deer and about 7 percent of the average value of a farmed or captive elk. CWD testing of cervids is recognizediii

by APHIS, the States, and cervid herd owners as essential to succe ssful control of this disease. Owners who choose confirmatory DNA testing will consider it a benefit, as evidenced by their pay ment for this voluntary , optional test. Most cervid operations are small entities. The rule will have a positive overall economic impact on affected entities large and small, and for the U.S. cervid industries generall y, in controlling the spread of CWD and facilitating interstate and international trade in cervids and cervid products.iv



### Table of Contents Summary
................................ ................................ ................................ .............................. i Introduction
................................ ................................ ................................ ......................... 1 Need for and Objectives of the Rule
................................ ................................ ................... 5 Significant Issues raised by Public Comment in response to the Initial Regulatory Flexibility

Anal ys is
................................ ................................ ................................ ............. 6 Comments filed by

the Small Business Administration in response to the Proposed Rule 6 Potentially

Affected Small Entities
................................ ................................ ..................... 6 Projected Reporting, Recordkeeping, and Other Compliance Requirements
..................... 7 Steps taken by

APHI S to minimize Significant Economic Impacts on Small Entities
...... 7 References
................................ ................................ ................................ ........................... 91



### Introduction The Regulatory

Flexibility

Act requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations and small governmental jurisdictions. This final regulatory flexibility

analy sis describes expect ed impacts of this rule on small entities, as required by s ection 60 4 of the Act. Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy (TSE) of cervids (deer, elk, and moose) . TSEs are caused by abnormal proteins known as prions. Fi rst recognized as a clinical "wasting" s yndrome in 1967 in mule deer in a wildlife research facility in northern Colorado, CWD was identified as a TSE in 1978. It is characterized by chronic weight loss leading to death. There is no known relationship be tween CWD and other TSEs of animals or people. The disease was first detected in U.S. farmed elk in 1997 , and was also diagnosed in a wild moose in Colorado in 2005. As of April 2013, CWD has been confirmed in wild deer and elk in 1 8 S tates and in 40 farmed elk herds and 20 farmed deer herds in 13 States
. This final rule affirms an interim final rule published in June 2012. The interim final rule amended a July

2006 final rule that established a Federal CWD Herd Certification Program (HCP) to control thi s disease in farmed or captive cervids. The July 2006 final rule set forth for participating owners herd management regulations, including CWD monitoring and testing requirements, and set interstate movement restrictions. We are adopting the interim final rule without changes.2

Deer and elk are farmed for breeding stock, velvet antler, meat, and sales to game parks and exhibits. Velvet antler, considered a medical/dietary aid, is produced primarily for Asian markets. Deer and elk meat, or venison, is a low
- fat, low
- cholesterol product that is marketed primarily to gourmet restaurants, for consumption by health conscious dieters. The breeding stock market satisfies the need for semen to be used for artificial insemination, replacement and start - up anima ls. There are no known commercial moose farming operations in the United States, although such operations may emerge in the future. Hard statistical data on the deer and elk farming industries is, at best, limited. The two major industry

associations

– the North American Elk Breeders Association (NAEBA) and the North American Deer Farmers Association (NADFA)

– compile very little data apart from their own membership, and only sparse data on deer and elk farms are included in Census of Agriculture data. In 2007, there were 68,251 elk on 1,917 elk farms, compared to 97,901 elk on 2,371 farms in 2002, that is, there were 5
- ye ar declines of 30 percent and 19 percent in the number of elk and number of farms, respectivel y. According to NAEBA, the number of elk per farm varies, from a high of “500 plus” for commercial farms to a low of about 10 for hobby farms. The value of each elk held also varies, depending on the type of animal (e.g., bull, cow, calf), market conditions, and other factors. In 2012, NAEBA es timated the average value of an elk at $2,200, with a ty pical high
- end value of about $6,500. Based on the estimated average of $2,200 per animal, the value of all 68,251 elk on U.S. farms in 2007 is estimated to have been about $150 million (68,251 x $2, 200). In 2007, there were 269,537 deer on 5,654 deer farms, compared to 286,863 deer on 4,901 farms in 2002, that is, over this 5
- ye ar period, the number of farmed deer declined by 63

percent, but the number of farms increased b y 15 percent. The number o f deer per farm varies, from a high of about 3,000 for commercial farms to a low of about 5 for hobby farms. The value of deer also varies, depending on the t ype and breed (e.g., red, white
- tailed, fallow) and market conditions. A NADFA estimate reported in the economic anal ys is for the July 2006 final rule put the average per animal value of all deer on member farms at $1,687, with the high
- end value at $4,000 and the low
- end value at $375. Based on an average of $2,000 per animal, the value of all 269, 537 deer on U.S. farms in 2007 is estimated to have been about $539 million (269,537 x $2,000). With publication of this final rule and concurrent removal of the suspension of the July 2006 final rule, farmed or captive deer and elk herd owners who choos e to participate in the voluntary national CWD Herd Certification Program will have to meet program requirements for animal identification, testing, and herd management. The p rogram will be a cooperative effort by APHIS, State animal health and wildlife a gencies, and cervid herd owners. State responsibilities will include restricting interstate movement of farmed or captive deer and elk; imposing quarantine and movement restrictions; and conducting traceback and epidemiological investigation of CWD
- positiv e, CWD
- exposed, and CWD
- suspect cervids; requiring premises identification and animal identification of all participating herd owners; and testing of all animals that die or are killed and requiring appropriate disposal of the carcasses. Herd owners will be responsible for identifying each animal in their herds through approved means of identification before they reach 12 months of age, when they are moved off the premises, or when a herd inventory is conducted. They

must also maintain an inventory that includes records on the species, age, and sex of each animal; the date of acquisition and source of4

each animal that was not born into the herd; the date of disposal and destination of animals removed from the herd; and the animal identification associated with each animal. A phy sical inventory

will be required at the time a herd is enrolled in a CWD program, after which a ph ys ical inventory will need to be performed within 3 years of the previous phy sical inventory . An annual herd inventory

—including a review of owner records and an observation of the herd’s unrestrained animals in a viewable, enclosed area

— will continue to be required, but the animals will not necessaril y need to be physically assembled and restrained. Herd owners must also maintain perimeter fencing adequate to prevent CWD from being spread through contact with wild cervids, and introduce into the herd onl y animals from other HCP herds so that those animals pose a known risk of infection with CWD. Herd owners will be required to report to APHI S or the State all animals that escape or disappear, and all animals that die or are killed and make their carcasses available for tissue sampling and testing. The regulations will allow for optional confirmatory DNA test provisions for animals th at test CWD
positive. Participating herds will be assigned a herd status based on how long they have conducted continuous CWD surveillance in the program without any CWD positive findings. Herds already participating and in compliance in an Approved Stat e HCP will receive credit. After 5 ye ars of participation with no CWD
- positive or CWD
- exposed animals, the herd will be designated a Certified herd. Herds that contain CWD
- positive or CWD
- exposed animals will lose their status and may

only reenroll in th e program after entering into a herd plan designed to address possible sources of infection and monitor the animals for CWD. Herds containing CWD
- suspect animals will be placed in suspended status and further investigated to determine appropriate actions. A herd may add animals of the same or higher status without changing its5

status, but if it adds animals of a lower status, the receiving herd reverts to the program status of the sending herd. Adding animals from a nonparticipating herd restarts the herd' s participation in the program. The following animals will be eligible for interstate movement: farmed cervids from Certified herds, if accompanied b y a certificate; free
- ranging (wild) cervids captured for interstate movement or release, if identified w ith two forms of animal identification

– including one official identification

– and if the source population has been documented to be low risk for CWD based on a surveillance program; cervids moved for slaughter, if identified and accompanied b y a certif

icate; research animals, if accompanied by a permit granted b y the Administrator; and animals approved on a case
- by
- case basis by the Administrator. The July 2006 final rule, as amended, will set minimum requirements for interstate movement of farmed or c aptive cervids with respect to CWD, but will not preempt more restrictive State laws and regulations, with the exception of cervids transiting a State en route to another State. 

### Need for and Objectives of the Rule The presence of CWD in cervids causes sign ificant market losses to U.S. producers. Domestic prices of elk and deer are depressed b y fear of CWD. Canada prohibits the importation of elk from Colorado and Wyoming and now requires that other cervids be accompanied by a certificate stat ing that CWD has not be diagnosed in the herd of origin. The Republic of Korea has suspended the importation of deer and elk and their products from the United States and Canada. APHI S estimates that through FY 2011, approximately 140 farmed cervid premises having app roximately

7,500 animals that were either CWD
- positive or CWD
- exposed have been depopulated using APHIS indemnity funding. The Herd Certification Program will enable6

timely identification of herds infected with CWD . The program’s establishment of herd management practices and minimum requirements for the interstate movement of farmed or captive deer, elk, and moose will help control the incidence of CWD and prevent its spread
. 

### Significant Issues **raised by**  **Public Comment in response to**  **the Initial Regulatory Flexibility Analysis**  The interim final rule specificall y requested comments with respect to preemption of State and local laws and regulations regarding CWD. There were no significant issues raised b y the public in response to the initial regu latory flexibility

anal ys is
. 

### Comments filed **by the Small Business Administration in response to the**  **Proposed Rule** There were no comments filed by the Small Business Administration in response to the interim final rule. 

### Potentially **Affected Small Entities**  This rule will directly

affect cervid herd owners. As reported in the Census of Agriculture , in 2007 there were 1,917 elk farms that had a total elk population of 68,251, and 5,654 deer farms that had a total of 269,537 deer . We do not have information on the size distribution of these holdings . However, it is reasonable to assume that most of these operations were small in size, based on the Small Business Administration's (SBA) standard of annual gross receipts of not more than $750,000 for the indus try category NAICS 112990, All Other Animal Production. In 2007, there were 61,973 U.S. farms categorized within NAICS 112990, a classification composed of establishments primarily engaged in raising certain animals (including deer and elk, but excluding cattle, hogs and pigs, poultry , sheep and goats, animal7

aquaculture, apiculture, horses and other equines, and fur
- bearing animals). For all 61,973 farms, the average market value of agricultural products sold in 2007 was about $38,205, well below the SBA 's small
- entity threshold of $750,000. To the extent that the rule prevents the spread of CWD in farmed cervids in the United States, herd owners will benefit over the long term. While helping to prevent disease spread, the rule will also provide herd own ers with increased access to out
- of
- State markets. By

providing a minimum basis for equivalency between State programs, the rule will facilitate the safe movement of animals between States. It will also signal that a safe cervid market exists in the United States that can be tapped internationall y for specialized products such as antler velvet. H erd owners who sell their cervids in
- State will benefit as well , since the Herd Certification Program wi ll reduce their disease risk when receiving animals from other States. 

### Projected Reporting, Recordkeeping, and **Other Compliance**  **Requirement s**  In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), we publishe d a notice in the Federal Register on January 24, 2012 (77 FR 3434
- 3435, Docket No. APHIS
- 2011
- 0032), announcing our intention to reinstate the information collection associated with the July 2006 final rule and soliciting comments on it. The changes made to the July

2006 final rule themselves have no new mandatory reporting, recordkeeping, or other compliance requirements for U.S. entities. 

### Steps taken by APHIS to minimize Significant Economic **Impact s**  **on Small Entities**8

Based on our review of available information, APH IS does not expect the rule to have a significant economic impact on small entities. In the absence of significant economic impacts, we have not identified alternatives that would minimize such impacts.9



### References Census of Agriculture, 2007, http://www.agcensus.usda.gov/Publications/2007/Full_Report/index.asp Census of Agriculture, 2002, http://www.agcensus.usda.gov/Publications/2002/Volume_1,_Chapter_1_US/ Economic Census, 2002, http://www.census.gov/econ/census02/ Small Business Adm inistration. A Guide for Government Agencies How to Comply with the Regulatory

Flexibility

Act. http://www.sba.gov/advo/laws/regflex.html Small Business Administration. Small Business Standard Match to North American Industry Classification Sy stem http://www.sba.gov/size/sizetable2007.html